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Effects of Pressure Biofeedback Training Versus Bolster Foam Roll Training for Pain, Muscles Activation, and Quality of Life Among Knee Osteoarthritis Patients

23 juli 2026 bijgewerkt door: Lahore University of Biological and Applied Sciences

Effects of Pressure Biofeedback Training Versus Bolster Foam Roll Training for Pain, Muscle Activation and Quality of Life Among Knee Osteoarthritis Patients

The current study will be a single-blinded, two-arm parallel group randomized clinical trial involving 48 participants. The trial will compare Pressure Biofeedback training with Bolster Foam Roll training. Interventions will be delivered three times per week for eight weeks. The primary outcomes will include pain intensity, functional status, and muscle activation. Assessments will be conducted at baseline (week 0), mid-intervention (week 4), post-intervention (week 8), and follow-up (week 12). The study will be conducted at the outpatient departments of Sir Ganga Ram Hospital (SGRH) and Mayo Hospital Lahore. The hypothesis is that there is a difference between Pressure Biofeedback Training and Bolster Foam Feedback Training regarding pain reduction, muscle activation, and patient-reported quality of life compared to Bolster Foam rolling training among knee osteoarthritis patients.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Knee Osteoarthritis is a common degenerative joint disease that causes pain, disability, and reduced quality of life. Grade II knee OA represents a mild but symptomatic stage where targeted rehabilitation can help slow disease progression and improve joint function. A major challenge in these patients is Arthrogenic Muscle Inhibition (AMI), which limits rehabilitation progress by reducing the normal activation of the quadriceps muscles due to pain and swelling. This leads to noticeable muscle weakness and difficulty performing functional movements.To counteract AMI, rehabilitation protocols integrate biofeedback mechanisms to enhance motor learning. A foam bolster is normally used to provide tactile feedback, while a Pressure Biofeedback Unit (PBU) provides a visual target to help patients activate their muscles better. This study will evaluate whether the addition of a quantifiable visual target (PBU) offers superior clinical efficacy over traditional tactile-based Bolster Foam feedback.A total of 48 participants will be randomly assigned in a 1:1 ratio to either Group A (Pressure Biofeedback) or Group B (Bolster Foam Feedback). Both groups will undergo 3 supervised sessions per week for 8 weeks. Each session will last 45 minutes and include a standard baseline conventional exercise protocol. The groups will differ during the targeted isometric intervention phase, using either a PBU or a bolster foam for feedback. Outcome measures will be assessed at predefined time points to evaluate changes in pain, function, and muscle activation. Findings from this trial aim to guide clinical practice by identifying the most effective feedback method for routine rehabilitation

Studietype

Ingrijpend

Inschrijving (Geschat)

48

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Dr. Shoaib Waqas Waqas

Studie Locaties

  • Pakistan
      • Lahore, Pakistan, 54000
        • Werving
        • Lahore University of Biological and Applied Sciences
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Patient diagnosis with Grade II knee Osteoarthritis.

Age between 45 and 65 years, encompassing the typical onset of symptomatic OA.

Both genders Male and Female are included.

Symptomatic patients meeting the following American College of Rheumatology criteria: average pain score ≥ 3 in the last week on the numerical rating scale, morning stiffness < 30 min, and joint crepitus

Exclusion Criteria:

History of knee surgery (TKA, HTO, ACLR) or arthroscopy in the affected knee within the last 6 months.

Intra-articular corticosteroid or hyaluronic acid injections within the last 3 months.

Neurological conditions affecting lower limb motor control (e.g., Stroke, Parkinson's, Radiculopathy).

Acute infection, tumor, or fracture around the knee joint.

Severe cognitive impairment or inability to follow visual/tactile cues.

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Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Pressure Biofeedback Training
Participants will receive 45-minute sessions including warm-up and conventional physiotherapy. For targeted isometric training, participants lie supine with a Pressure Biofeedback Unit airbag under the popliteal fossa inflated to 60 mmHg. They press the knee downward to move the dial up 20-40 mmHg, holding for 10 seconds across 3 sets of 10 repetitions
Ander: pressure Biofeedback Training
This intervention combines a standard land-based therapeutic exercise protocol with visual feedback for targeted isometric quadriceps activation. During a 45-minute session, participants first complete warm-up and conventional strengthening exercises (e.g., straight leg raises, hip abduction, step-ups). For the specific isometric component, participants lie supine with a Pressure Biofeedback Unit (PBU) airbag placed under the popliteal fossa, inflated to a baseline of 60 mmHg. They are instructed to press the knee downward to increase the dial reading by 20-40 mmHg and hold it steady for 10 seconds. This is performed for 3 sets of 10 repetitions to counteract Arthrogenic Muscle Inhibition (AMI).
Actieve vergelijker: Bolster Foam Feedback Training
Participants will receive the same 45-minute sessions with warm-up and conventional physiotherapy. For targeted isometric training, participants lie supine with a firm high-density foam bolster under the knee. They are instructed to "crush the foam" into the table to feel the resistance, holding for 10 seconds across 3 sets of 10 repetitions
Ander: Bolster Foam Roll Training
Participants will complete a 45-minute exercise session consisting of a warm-up and conventional physiotherapy exercises (straight leg raises, side-lying hip abduction, step-ups, mini-squats, and stretches). For the targeted isometric component, participants are positioned supine with a firm high-density foam bolster placed under the knee. They are instructed to "crush the foam" into the table to feel the physical resistance, holding the contraction for 10 seconds. They will complete 10 repetitions across 3 sets.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Intensity assessed via Numeric Pain Rating Scale (NPRS)
Tijdsspanne: Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
Knee pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). Participants will rate their current knee pain, as well as their worst and best pain over the last 24 hours, on an 11-point integers scale. On this scale, 0 indicates "No pain" and 10 indicates "worst pain imaginable
Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
Functional Status and Quality of Life assessed via WOMAC Index
Tijdsspanne: Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be utilized as the primary outcome measure for functional status and disease-specific quality of life. The index comprises 24 items covering three dimensions: Pain (Score range: 0-20), Stiffness (Score range: 0-8), and Physical Function (Score range: 0-68). Items are scored on a 5-point Likert scale (0=none to 4=Extreme), where higher aggregate scores indicate greater disability
Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
Quadriceps Muscle Activation assessed via Modified Sphygmomanometer Test (MST)
Tijdsspanne: Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)
Quadriceps muscle activation will be assessed using the Modified Sphygmomanometer Test. A cuff is placed under the popliteal fossa and inflated to a baseline of 40 mmHg. The patient performs a Maximum Voluntary Isometric Contraction (MVIC), and the peak pressure sustained for 3 seconds is recorded. The final outcome is the change in pressure (Peak - Baseline) calculated from the average of 3 trials
Baseline (week 0), Mid-Intervention (week 4), Post-Intervention (Week 8), and Follow-up (Week 12)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Lahore University of Biological and Applied Sciences

Onderzoekers

  • Hoofdonderzoeker: WHO, Lahore University of Biological and Applied Sciences

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2026

Primaire voltooiing (Geschat)

15 augustus 2026

Studie voltooiing (Geschat)

15 oktober 2026

Studieregistratiedata

Eerst ingediend

23 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juli 2026

Eerst geplaatst (Werkelijk)

28 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UBAS/ERB/26/04/017

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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